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Item 7. Management’s Discussion and Analysis

2025-10-16 compared with 2024-10-29 · 106 added, 113 removed, 116 unchanged (65% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

following discussion and analysis should be read in conjunction with our consolidated financial statements and related notes

included elsewhere in this Annual Report.

This discussion and other parts of this Annual Report contain forward-looking statements

based upon current expectations that involve risks and uncertainties.

Our actual results and the timing of selected events could

differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set

forth under “ Risk Factors ” and elsewhere in this Annual Report.

preparation of our consolidated financial statements in conformity with these accounting principles requires us to make estimates

and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial

statement date and reported amounts of revenue and expenses during the reporting period.

On an on-going basis, we review our

estimates and assumptions.

The estimates were based on historical experience and other assumptions that we believe to be reasonable

under the circumstances.

Actual results are likely to differ from those estimates or other forward-looking statements under

different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results

of operations.

Our actual results may differ materially as a result of many factors, including those set forth under the headings

entitled “ Special Note Regarding Forward-Looking Statements ” and “ Risk Factors ”.

following discussion and analysis should be read in conjunction with our consolidated financial statements and related notes included

elsewhere in this Annual Report.

This discussion and other parts of this Annual Report contain forward-looking statements based upon

current expectations that involve risks and uncertainties.

Our actual results and the timing of selected events could differ materially

from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “ Risk

Factors ” and elsewhere in this Annual Report.

preparation of our consolidated financial statements in conformity with these accounting principles requires us to make estimates and

assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial statement

date and reported amounts of revenue and expenses during the reporting period.

On an on-going basis, we review our estimates and assumptions.

The estimates were based on historical experience and other assumptions that we believe to be reasonable under the circumstances.

results are likely to differ from those estimates or other forward-looking statements under different assumptions or conditions, but

we do not believe such differences will materially affect our financial position or results of operations.

Our actual results may differ

materially as a result of many factors, including those set forth under the headings entitled “ Special Note Regarding Forward-Looking

Statements ” and “ Risk Factors ”.

is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care.

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Actual outcomes could differ from these estimates.

The financial statements include estimates which, by

their nature, are uncertain.

The impacts of such estimates are pervasive throughout the financial statements, and may require

accounting adjustments based on future occurrences.

Revisions to accounting estimates are recognized in the period in which the

estimate is revised and also in future periods when the revision affects both current and future periods.

The consolidated financial statements include

estimates which, by their nature, are uncertain.

The impacts of such estimates are pervasive throughout the consolidated financial

statements, and may require accounting adjustments based on future occurrences.

Revisions to accounting estimates are recognized in

the period in which the estimate is revised and also in future periods when the revision affects both current and future

critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized

in the consolidated financial statements are:

of the consolidated financial statement on a going concern basis, which contemplates the realization of assets and payments of liabilities

in the ordinary course of business.

of the consolidated financial statement on a going concern basis, which contemplates that the Company will be able to meet its commitments, continue operations and realize its assets

and discharge its liabilities in the normal course of business for at least twelve months from the date of approval of these Financial

Statements from the Board of Directors.

Should the Company be unable to continue as a going concern, it may be unable to realize the carrying

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equity method

in entities over which the Company does not have a controlling financial interest but has significant influence are accounted for using

the equity method, with the Company’s share of losses reported in the loss from equity method investments on the statements of

operation and comprehensive loss.

in entities over which the Company does not have a controlling financial interest but has significant influence are accounted for

using the equity method, with the Company’s share of losses reported in the loss from equity method investments on the

statements of operation and comprehensive loss.

The Company has a 63.1% interest in BC Therapeutics.

Management evaluates whether it has control over

the investee in accordance with the guidance of ASC 810, which requires judgment to assess factors such as power over significant activities

of the investee, exposure to variable returns, and the ability to affect those returns.

Based on this evaluation, management determines

whether control or significant influence is present for accounting purposes.

Management evaluates whether it

has control over the investee in accordance with the guidance of ASC 810, which requires judgment to assess factors such as power

over significant activities of the investee, exposure to variable returns, and the ability to affect those returns.

Based on this

evaluation, management concludes significant influence is present for accounting purposes.

New Accounting Policies Adopted

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of the year ended July 31, 2025, compared to the year ended July 31, 2024

costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;

and (ii) clinical trials and investigational

drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.

following is a breakdown of our research and development costs by project:

Year ended July 31,

Clinical trials

Pre-clinical projects

Chemical, Manufacturing and Control Costs (“CMC Costs”)

clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase 1/2a clinical trial.

Clinical trial

expenses increased in 2024 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.

a longer than expected overall

Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the

pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in

preparation for the upcoming clinical studies of Bria-OTS™.

clinical trial expenses are broken down as follows:

Year ended July 31,

Bria-IMT™ Pivotal Phase 3 study

Bria-IMT™ Phase 1/2a

Indirect research and development expenses allocated to trials

the year ended July 31, 2024 we pivoted from our Bria-IMT™ Phase 1/2a study to the Bria-IMT™ Pivotal Phase 3 Study.

projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.

Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional

pre-clinical program (sCD80).

Towards the end of 2024 the financial year end, we have slowed these programs in order to direct more attention

and resources to our clinical trials.

costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational

CMC costs decreased in 2024;

this reduction can be attributed to efficiencies gained in the manufacturing process and

a streamlined approach to quality control.

costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory

board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development

Other costs increased in 2024 as we investigated additional potential pre-clinical projects.

following is a breakdown of our research and development costs by nature of expenses:

Research costs are comprised primarily of (i) salaries and wages to Company

employees at our laboratory and in clinical development;

and (ii) clinical trials and investigational drug costs, which include the testing

and manufacture of our investigational drugs and costs of our clinical trials.

The following is a breakdown of our research and development costs by nature

Year ended July 31,

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Laboratory rent

Professional Fees

Share-based compensation

the year ended July 31, 2024, research costs totaled $27,177,807, compared to $15,336,638 for the same period in 2023.

The increase primarily

resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational drug costs, which

rose from $9,611,630 in 2023 to $20,890,266 in 2024.

Wages and salaries increased from $3,878,367 to $4,567,307, reflecting the hiring

of additional employees.

Additionally, non-cash share-based compensation expenses decreased from $1,072,592 in 2023 to $734,986 in 2024,

offsetting some of the overall increase in research and development expenses.

For the year ended July 31, 2025, total research,

development, and clinical trial costs amounted to $21,270,678 as compared to $27,177,807 for the year ended July 31, 2024.

was primarily driven by lower clinical trial sites and investigational drug costs, which declined from $20,885,903 in 2024 to $14,765,112

The reduction reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the

pivotal Phase 3 trial.

Wages and salaries increased from $4,567,307 in 2024 to $5,356,806 in 2025, reflecting the hiring of additional

employees to support ongoing research and clinical activities.

Laboratory rent rose to $457,320 in 2025, compared to $420,310 in 2024,

due to expanded use of facilities.

Supplies decreased, from $496,312 in 2024 to $470,208 in 2025, reflecting reduced consumable needs.

Depreciation expenses increased to $91,356 in 2025, compared to $68,626 in 2024.

The increase reflects a full year of depreciation on

equipment purchased in 2024 as no new equipment was purchased in 2025.

Professional fees increased from $4,363 in 2024 to $9,826 in 2025.

Share-based compensation expenses decreased significantly from $734,986 in 2024 to $120,050 in 2025, further contributing to the overall

reduction in research, development, and clinical trial expenses.

Clinical trial expenses for the period are as follows:

Year ended July 31,

Bria-IMT™ Pivotal Phase 3 study

Bria-IMT™ Phase 1/2a

Bria-OTS™ Phase 1/2a

trial expenses for the year ended July 31, 2025, were $14,953,296, compared to $15,833,879 during the year ended July 31, 2024.

is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting in significantly

lower associated costs in 2025.

As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources were increasingly directed toward

the pivotal Phase 3 study, which remains our primary focus.

In addition, we began incurring costs related to the Bria-OTS™ Phase

1/2a trial, which commenced in August 2024.

the year ended July 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $13,511,235, compared to $11,594,463 in 2024.

reflects the progression of the pivotal study, with higher expenditures on patient recruitment, treatment, and data-management activities

as the trial advanced through key operational milestones.

the year ended July 31, 2025, Bria-IMT™ Phase 1/2a costs were $1,013,828, down from $4,239,415 in 2024, reflecting the conclusion

of the study.

The remaining expenses primarily relate to final data analysis and study close-out activities.

the year ended July 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $428,233, compared to $nil in 2024, due to the initiation of the

Bria-OTS™ Phase 1/2a trial in August 2024.

and Administrative Expenses

the year ended July 31, 2024, general and administrative expenses amounted to $6,152,269 as compared to $7,935,626 for the year ended

July 31, 2023.

The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional fees and

share-based compensation expenses.

The Company has reduced general and administrative expenses in order to devote more resources to its

clinical program.

income (expenses), net

the year ended July 31, 2024, financial income, net amounted to $262,566, compared to $850,340 for the year ended July 31, 2023.

income for 2024 primarily consists of interest income of $288,018, offset by a foreign exchange loss of $25,450.

In comparison, for the

year ended July 31, 2023, interest income was $891,213, while foreign exchange losses totaled $40,873.

The decrease in financial income

from 2023 to 2024 reflects lower interest income due to reduced cash and cash equivalents available for investment in interest-bearing

For the year ended July 31, 2025, general and administrative expenses were $5,934,125, compared to $6,152,269 for

the year ended July 31, 2024.

Expenses remained relatively consistent year over year, with lower consulting, professional fees, and share-based

compensation largely offset by higher wages and salaries, travel, and other administrative costs.

the year ended July 31, 2025, finance income, net, was $114,511, compared to $262,566 for the year ended July 31, 2024.

was primarily due to lower interest income, which declined to $176,431 in 2025 from $288,018 in 2024, reflecting reduced average cash

balances available for investment.

The decrease was further impacted by the recognition of $36,979 in interest expense in 2025 compared

to nil in the prior year.

Foreign exchange losses were relatively consistent year over year, amounting to $24,941 in 2025 versus $25,452

for the period

Company reported a loss for the year ended July 31, 2024, of $4,791,466, compared to $20,302,394 for the year ended July 31, 2023.

loss in 2024 primarily stems from increased operational spending, particularly in research and development.

However, the decrease in

the fair value of the warrant liability substantially offset the increase in research and development expenses, leading to a significantly

lower reported loss for the year.

In contrast, the larger loss in 2023 is attributed to lower operational costs but a smaller decrease

in the warrant liability, which did not offset expenses to the same extent as in 2024.

This highlights the significant role the warrant

liability valuation plays in influencing the Company’s overall financial performance.

Company reported a net loss of $26,311,867 for the year ended July 31, 2025, compared to $4,791,466 in 2024.

The increase in net loss

was primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $758,364 in 2025 compared to

$28,242,472 in 2024.

This variance outweighed the reduction in research, development, and clinical trial expenses, which decreased from

$27,177,807 in 2024 to $21,270,678 in 2025, mainly reflecting lower clinical-trial and investigational-drug costs following the completion

of the Bria-IMT™ Phase 1/2a trial.

and Capital Resources

of July 31, 2024, the Company has a negative working capital of ($3,807,303) (July 31, 2023- $25,147,050) and an accumulated deficit of

$85,443,697 (July 31, 2023 - $80,652,231).

of July 31, 2025, the Company has a positive working capital of $15,948,588 (July 31, 2024 – negative $3,807,303) and an

accumulated deficit of $111,755,564 (July 31, 2024 - $85,443,697).

of July 31, 2025, the Company’s capital resources consist primarily of cash and cash equivalents, comprised mostly of cash on deposit

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no assurance that such a plan will be successful.

To this end, for several months during calendar year 2024, certain directors

and officers agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these

fees were paid in full.

Further, certain officers have indicated their willingness to receive a portion of their compensation

in shares of the Company, subject to applicable Nasdaq rules.

In addition, we continue to reduce expenditure on certain non-core

activities whilst maintaining our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.

the year ended July 31, 2024, the Company’s overall position of cash and cash equivalents decreased by $20,389,003 from the year

To this end, for several months during calendar year 2025, certain directors and officers

agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these fees were paid

Further, certain officers have indicated their willingness to receive a portion of their compensation in shares of the Company,

subject to applicable Nasdaq rules.

In addition, we continue to reduce expenditure on certain non-core activities whilst maintaining

our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.

the year ended July 31, 2025, the Company’s overall position of cash and cash equivalents increased by $10,493,808 from the year

ended July 31, 2024 (including effects of foreign exchange).

This decrease in cash can be attributed to the following:

This increase in cash can be attributed to the following:

Company’s net cash used in operating activities during the year ended July 31, 2025, was $28,170,520 as compared to $24,126,128

for the year ended July 31, 2024.

Although the operating loss was higher during the period ended July 31, 2024, this was offset by an

increase in accounts payable, such that the cash flows from operating activities during both periods were similar.

used in investing activities for the year ended July 31, 2025, was $7,646,000, as compared to $681,801 for the year ended July 31, 2024.

The amount in 2025 relates primarily to the purchase of short-term investments ($7,316,000) and an equity investment in BC Therapeutics

($330,000), and in the prior year, to the purchase of property, plant and equipment ($456,801) and an equity investment in BC Therapeutics

generated from financing activities for the year ended July 31, 2025, was $45,448,239, as compared to $4,418,926 for the year ended July

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis